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On September 10, 2015, plaintiffs filed a new class action lawsuit against the manufacturers of diabetes drug Invokana: Janssen Pharmaceuticals and parent company Johnson & Johnson. Representative plaintiff Rosalba Joudry, a resident of Ontario, filed the case on behalf of all persons in Canada who took Invokana and then suffered serious kidney problems.

In the U.S. the FDA warned in May 2015 that Invokana had been linked to diabetic ketoacidosis (DKA), a dangerous and potentially life-threatening condition. They issued the warning after receiving 20 reports of DKA between 2013 and 2014 of patients with type 2 diabetes who were taking Invokana and were hospitalized for DKA.

Invokana has also been linked to kidney problems, which is the subject of this potential Canadian class-action lawsuit.

Plaintiff Taking Invokana Suffers Kidney Failure

According to the complaint, Joudry started taking Invokana in October 2014 to manage her high blood glucose levels associated with her type 2 diabetes. The FDA approved Invokana for this use in March 2013.

Around June 2015, Joudry states she saw an advertisement on a U.S. television commercial warning Invokana users about the risk for DKA and kidney failure. She immediately contacted her doctor and made an appointment. Tests conducted by her doctor showed that she was experiencing kidney failure.

Joudry was shocked by the diagnosis. She states that her doctor didn’t alert her to the risk, and that the warnings on the Invokana label were inadequate and downplayed the seriousness of the drug’s potential side effects. Had she known about the potential for kidney failure, she states that she would never have taken the drug.

Invokana Linked with Kidney Stones and Kidney Failure

Invokana was approved for sale in Canada after it was approved in the U.S.—in May 2014. The drug belongs to a class of medications called SGLT2 inhibitors that blocks the kidneys from reabsorbing glucose, allowing that glucose to be flushed out of the body via the urine.

In the initial trials used to gain FDA approval of the drug, there was some evidence of bone health issues, cardiovascular problems, and liver abnormalities, but the FDA allowed the approval to go through with the stipulation that the manufacturer conduct additional studies to further determine Invokana’s safety. The administration did express concern about the long-term use of the drug, stating that the changes in kidney function seen in the studies could potentially put patients at risk of kidney injury.

Within just a year of being on the U.S. market, Invokana was associated with 457 reports of adverse events, as reported by the Institute for Safe Medications Practices (ISMP) in their QuarterWatch publication. Among the problems reported were urinary tract infections, kidney stones, and kidney impairment or failure.

Plaintiff Seeks in Excess of $1 Billion in Damages for Injured Class

Joudry asserts in her complaint that Janssen failed to provide clear, complete, and current warnings on the Invokana label, and that they have ignored information connecting the drug with kidney and other problems. Instead of properly warning of these problems, the manufacturer has continued to promote the product as safe.

On behalf of all potential class members, Joudry seeks general damages in excess of $500 million and special damages in excess of $500 million, for a total of $1 billion, as well as punitive damages. The class action has not yet been certified, which is required under Canadian law before it can proceed. Certification is expected within the next six months.

One Comment

  1. Gravatar for Sharonbond
    Sharonbond

    I'm having palpitations like that coming through my throat is that one of the side effects and I'm nervous like

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